Global healthcare aid agencies such as UNITAID and Medicines Sans Frontieres (MSF) have begun to lobby for a “patent pool” of HIV/AIDS drugs. Indian generic makers of these drugs, such as Ranbaxy, Cipla, Natco, Hetero Drugs, Strides Arcolab and Aurobindo, will benefit immensely if the effort succeeds.
The idea was mooted by UNITAID in July last year. Under this, the patent holders —companies, researchers or universities —will voluntarily offer, under certain conditions, the intellectual property related to their inventions to the pool. Any company that wants to use the intellectual property to produce or develop medicines will be able to seek a licence from the pool against payment of a royalty.
The pool would be operated by a one-stop shop licensing agency that would manage licences, negotiations as well as receipt and payment of royalties. This would provide an alternative to complex negotiations and litigation over patent rights and help faster availability of lower-priced medicines. Without having to wait for patents to expire, which usually takes 20 years, producers would be able to make generic versions under pre-determined licensing conditions.
A team of UNITAID, MSF and other agencies associated with the programme are planning to conduct road shows and lobby with industry and the new Indian government. UNITAID would also present the concept before the World Health Assembly in Geneva before mid-May, said sources.
Industry experts say of the 20-plus common anti-retroviral, which include fixed-dose combinations of second-line and new-generation drugs, many are patent-protected and Indian companies cannot legally make these. India introduced a product patent regime in 2005 under which any drug innovated after 1995 and patented in India cannot be made in the country without a licence from the innovator.
Two new antiretrovirals, etravirine (brand Intelence of Johnson and Johnson), and raltegravir (brand Sentress produced by Merck & Co), have been patented in India and many others are pending grant of patent. Such anti-retrovirals, individually or in combination, will remain out of generic production unless the Indian government grants compulsory licences.
Indian generic companies which manufacture copycat drugs at a fraction of the prices of patent-protected drugs are the largest suppliers of cheap HIV/AIDS drugs globally, treating 220,000 patients every year. So far, these companies have not revealed their revenues from supply of HIV/AIDS drugs. If new generation drugs for treating HIV/AIDS manufactured by innovator companies cost between $600-$1000 per patient every year, Indian companies have the ability to supply reverse-engineered or copycat versions at $150-$300 per patient every year.
An estimated 33 million people have HIV/AIDS today and of the approximately 9.7 million in need of anti-retroviral treatment (ART), only around three million are receiving it. India is estimated to have 2.4 million HIV/AIDS patients as of 2008, according to various sources.
“The concept is good, but it can succeed only with the support of the multinational drug lobby which markets such drugs for huge profits. We are yet to receive any invite to participate in this project and we wish to refrain from commenting on it,” said an executive with one of the generic HIV/AIDS drug makers in India.
“The concept has to evolve and requires support from crucial countries such as India, which has the largest number of generic drug makers,” said Leena Menghaney, project manager, India, Campaign for Access to Essential Medicines of MSF.
GlaxoSmithKline, the largest drug maker in Europe, has said it will create a pool of about 300 patents related to neglected diseases such as malaria and tuberculosis.